DWP · Class II · 21 CFR 870.4475

FDA Product Code DWP: Dilator, Vessel, Surgical

Leading manufacturers include Fehling Surgical Instruments, Inc..

20
Total
20
Cleared
116d
Avg days
1979
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Dilator, Vessel, Surgical Devices (Product Code DWP)

20 devices
1–20 of 20

About Product Code DWP - Regulatory Context

510(k) Submission Activity

20 total 510(k) submissions under product code DWP since 1979, with 20 receiving FDA clearance (average review time: 116 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.

DWP devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →